Abstract
Objective: To assess the feasibility of conducting a randomised controlled trial of a home-based virtual reality system for rehabilitation of the arm following stroke.
Design: Two group feasibility randomised controlled trial of intervention versus usual care.
Setting: Patients’ homes.
Participants: Patients aged 18 or over, with residual arm dysfunction following stroke and no longer receiving any other intensive rehabilitation.
Interventions: Eight weeks’ use of a low cost home-based virtual reality system employing infra-red capture to translate the position of the hand into game play or usual care.
Main measures: The primary objective was to collect information on the feasibility of a trial, including recruitment, collection of outcome measures and staff support required. Patients were assessed at three time points using the Wolf Motor Function Test, Nine-Hole Peg Test, Motor Activity Log and Nottingham Extended Activities of Daily Living.
Results: Over 15 months only 47 people were referred to the team. Twenty seven were randomised and 18 (67%) of those completed final outcome measures. Sample size calculation based on data from the Wolf Motor Function Test indicated a requirement for 38 per group. There was a significantly greater change from baseline in the intervention group on midpoint Wolf Grip strength and two subscales of the final Motor Activity Log. Training in the use of the equipment took a median of 230 minutes per patient.
Conclusions: To achieve the required sample size, a definitive home-based trial would require additional strategies to boost recruitment rates and adequate resources for patient support.
Introduction
Approximately 70% of patients experience impaired arm function after a stroke, and it is estimated that 40% of survivors are left with reduced functioning in the affected arm.1 There is now strong evidence from high-quality trials to support intensive repetitive task-oriented training for recovery after stroke.2 Recent studies3have found improvements in patients as much as 6 months post stroke, long after they have been discharged from any formal rehabilitation. Consequently there is a need to find the best way to support survivors once they stop accessing formal services.4
One route through which this may be achieved is the adoption of virtual reality and interactive video gaming which have emerged as new treatment approaches in stroke rehabilitation.5,6 The emergence of commercial gaming consoles has led to their adoption by therapists in clinical settings.7,8 These consoles have the advantages of mass acceptability, easily perceived feedback and most importantly, they are affordable. A disadvantage however, is that the games are not specifically designed for therapeutic use and while the games encourage movements of the arm, none capture sufficient information about the position of the fingers to be useful in the rehabilitation of the hand.
We developed a low cost home-based system for rehabilitation of the arm and hand designed to be flexible and motivating in order to improve adherence. Given the home-based, self-directed nature of the intervention and the introduction of new technology, a feasibility randomised controlled study was carried out in line with the MRC Framework for Complex Interventions.9 In preparation for an evaluation of the effectiveness of the intervention, the feasibility randomised controlled study aimed to answer the following questions:
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Can we recruit patients?
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Can we collect outcome measures?
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What sample size is indicated by the outcome measures collected?
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How much researcher and therapist support was required?

